Abbreviated
|
|
Product
|
Sponsor
|
Date Approved
(Application No.)
|
|
Acarbose, 25 mg, 50 mg and 100 mg tabs.
|
Impax
|
5/14/2009
(78-441)
|
|
Amlodipine besylate, 2.5 mg, 5 mg and 10 mg tabs.
|
Alkem
|
5/4/2009
(78-925)
|
|
Butorphanol tartrate, 1 mg/1 mL and 2 mg/1 mL inj.
|
Hikma Farmaceutica
|
5/1/2009
(78-400)
|
|
Divalproex sodium, EQ 250 mg valproic acid and EQ 500 mg valproic acid extended-release tabs.
|
Impax
|
5/6/2009
(78-791)
|
|
Ergocalciferol, 50,000 IU caps.
|
Orit Labs
|
5/20/2009
(40-833)
|
|
Famotidine, 20 mg and 40 mg tabs.
|
Alembic
|
5/22/2009
(78-916)
|
|
Galantamine HCl, EQ 4 mg base, EQ 8 mg base and EQ 12 mg base tabs.
|
Mylan
|
5/29/2009
(77-590)
|
|
Galantamine HCl, EQ 8 mg base, EQ 16 mg base and EQ 24 mg base extended-release caps.
|
Impax
|
5/27/2009
(78-484)
|
|
Hydralazine HCl, 10 mg, 25 mg, 50 mg 100 mg tabs.
|
Glenmark
|
5/29/2009
(90-527)
|
|
Levofloxacin, 250 mg, 500 mg and 750 mg tabs.
|
Lupin
|
5/13/2009
(78-424)
|
|
Medroxyprogesterone acetate, 150 mg/mL inj.
|
Sandoz
|
5/20/2009
(78-711)
|
|
Meloxicam, 7.5 mg and 15 mg tabs.
|
Strides Arcolab
|
5/13/2009
(77-928)
|
|
Mycophenolate mofetil, 250 mg caps.
|
Teva
|
5/6/2009
(65-491)
|
|
Mycophenolate mofetil, 250 mg caps.
|
Zydus
|
5/4/2009
(65-433)
|
|
Mycophenolate mofetil, 250 mg caps.
|
Mylan
|
5/4/2009
(65-520)
|
|
Mycophenolate mofetil, 250 mg caps.
|
Accord
|
5/4/2009
(90-253)
|
|
Mycophenolate mofetil, 500 mg tabs.
|
Accord
|
5/4/2009
(65-416)
|
|
Mycophenolate mofetil, 500 mg tabs.
|
Teva
|
5/4/2009
(65-457)
|
|
Mycophenolate mofetil, 500 mg tabs.
|
Zydus
|
5/4/2009
(65-477)
|
|
Mycophenolate mofetil, 500 mg tabs.
|
Mylan
|
5/4/2009
(65-521)
|
|
Polyethylene glycol 3350; sodium chloride; sodium bicarbonate; potassium chloride, 420 g; 11.2 g; 5.72 g; 1.48 g oral solution
|
Novel Labs
|
5/27/2009
(90-019)
|
|
Prednisolone sodium phosphate, EQ 15 mg base/5 mL oral solution
|
Vintage
|
5/26/2009
(79-010)
|
|
Ranitidine, 15 mg syrup
|
Wockhardt
|
5/26/2009
(79-211)
|
|
Ranitidine, 15 mg syrup
|
Dr. Reddy's
|
5/26/2009
(90-102)
|
|
Resperidone, 0.5 mg and 2 mg orally disintegrating tabs.
|
Zydus
|
5/1/2009
(78-516)
|
|
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs.
|
Hikma
|
5/26/2009
(78-740)
|
|
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs.
|
West Ward
|
5/29/2009
(78-740)
|
|
Sulfacetamide sodium, 10% topical lotion
|
Taro
|
5/20/2009
(78-668)
|
|
Terbutaline sulfate, 1 mg/mL inj.
|
Hikma Farmaceutica
|
5/20/2009
(78-630)
|
|
Triamcinolone acetonide, 10 mg/mL suspension inj.
|
Sandoz
|
5/27/2009
(90-166)
|
|
Ursodiol, 250 mg and 500 mg tabs.
|
Teva
|
5/13/2009
(79-184)
|
|
Tentative Abbreviated
|
|
Alfuzosin HCl, 10 mg extended-release tabs.
|
Sun
|
5/6/2009
(79-057)
|
|
Lamivudine/zidovudine, 150 mg/300 mg tabs.
|
Macleods
|
5/29/2009
(90-679)
|
|
Lamivudine; zidovudine, 200 mg tabs.
|
Hetero
|
5/7/2009
(22-356)
|
|
Losartan potassium/hydrochlorothiazide, 50 mg/12.5 mg and 100 mg/25 mg tabs.
|
Roxane
|
5/14/2009
(77-732)
|
|
Montelukast sodium, 10 mg tabs.
|
Teva
|
5/21/2009
(78-605)
|
|
Montelukast sodium, 10 mg tabs.
|
Mylan
|
5/27/2009
(79-103)
|
|
Moxifloxacin HCl, 0.5% ophthalmic solution
|
Teva
|
5/14/2009
(78-073)
|
|
Oxaliplatin, 5 mg/mL inj.
|
Ebewe
|
5/22/2009
(78-812)
|
|
Oxaliplatin, 50 mg and 100 mg inj.
|
Fresenius Kabi Oncol
|
5/22/2009
(78-810)
|
|
Oxaliplatin, 50 mg and 100 mg inj.
|
Hospira
|
5/22/2009
(78-815)
|
|
Oxaliplatin, 50 mg and 100 mg inj.
|
Sun
|
5/22/2009
(78-818)
|
|
Oxaliplatin, 50 mg/10 mL and 100 mg/20 mL inj.
|
Teva
|
5/22/2009
(22-160)
|
|
Ropivacaine HCl, 5 mg/mL (0.5%) inj.
|
Navinta
|
5/13/2009
(78-601)
|
|
Sumatriptan succinate, 25 mg, 50 mg and 100 mg tabs.
|
Sandoz
|
5/4/2009
(76-976)
|
|
Sumatriptan succinate, 25 mg, 50 mg and 100 mg tabs.
|
Orchid
|
5/5/2009
(78-284)
|
|
Zoledronic acid, 4 mg/5 mL inj.
|
Pharmaforce
|
5/20/2009
(90-330)
|
